Preclinical data generated in our non-human primate (NHP) model of face vascularized composite allografts (VCA) demonstrated immunosuppressive benefit of vascularized bone marrow (VBM) as a component of immunosuppressive therapy.

We performed a clinical face transplant with large volume VBM components consisting of mandible and maxilla in a patient with a large midface injury. The patient received alemtuzumab induction, and maintenance therapy with tacrolimus, mycophenolate mofetil (MMF) and prednisone taper. Clinical laboratory tests, biopsies, immunogenetic analyses, and flow cytometry were performed at defined intervals.

Initial lymphocyte depletion was significant with CD3 and CD4 counts of 5 and 3 cells/uL that increased to 41 and 27 cells/uL by month 5. Serial peripheral blood analysis has demonstrated no evidence of donor chimerism by short tandem repeat or flow cytometric analysis. Tregs varied between 0 and 15.9% (mean 8.4%). Low levels of donor specific antibody to DR10 existed pre-transplant (mean 1317 MFI, range 774-2143 MFI), and did not change during his post-transplant course (mean 1349 MFI, range 253-2112 MFI). Mild C4d positivity was detected in venules. Tacrolimus levels were decreased from means of 12.3 ng/mL in the first 90 days to 7.5 ng/mL in the second 90 days. Current immunosuppressive regimen consists of tacrolimus (level 6.6 ng/mL), prednisone 10 mg and MMF 1g bid. The patient had one episode of Banff grade 1 rejection on day 27 treated with intravenous steroids that resolved without additional rejection episodes. The patient is currently 8 months post-transplant with excellent immunologic and aesthetic outcomes.

Clinical face VCA with large component VBM provided good immunologic outcomes with modest immunosuppressive requirements at 8 months. Our clinical face VCA did not demonstrate evidence of chimerism, but unlike preclinical studies, potent T cell depletion was utilized. Similar to preclinical studies, alloantibody has not developed and reduction of immunosuppression has been well tolerated.

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